A Phase 3 Study of [177Lu]Ludotadipep for Metastatic Castration-Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age19+
SponsorFutureChem
About this trial
Primary Efficacy Endpoint
\- Radiographic Progression-Free Survival (rPFS): rPFS is defined as the time from randomization to radiographic disease progression (PD), as assessed by Blinded Independent Central Review (BICR) according to PCWG3-modified RECIST version 1.1, or death from any cause, whichever occurs first.
rPFS will be analyzed using the Kaplan-Meier method. The median survival time and corresponding two-sided 95% confidence intervals (CIs) will be estimated for both the investigational and control arms, and Kaplan-Meier curves will be presented.
A comparison between the investigational and control arms will be performed using a stratified Cox proportional hazards regression model. The model will be adjusted for the following stratification factors: nomogram score (≥178 vs \<178), ECOG Performance Status (0 or 1 vs 2), prior use of cabazitaxel before randomization (yes vs no), and receipt of best supportive care alone (yes vs no). The p-value will be reported.
Ties in event times will be handled using the Efron method. The hazard ratio (HR) of the investigational arm relative to the control arm and its corresponding two-sided 95% confidence interval will be provided.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult male aged ≥19 years at the time of written informed consent.
Histologically, pathologically, or cytologically confirmed prostate adenocarcinoma without small cell features.
PSA progression: Minimum PSA level of ≥2.0 ng/mL with at least two consecutive increases at intervals of ≥1 week.
At least one metastatic lesion documented by CT, MRI, or bone scan within 4 weeks prior to baseline.
Disqualifiers
PSMA-targeted radioligand therapy
Systemic radionuclide therapy within 24 weeks prior to the first dose of study intervention (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemi-body irradiation)
Any other anticancer therapy (including cytotoxic chemotherapy, immunotherapy, biologic therapy, or targeted therapy) within 4 weeks prior to randomization
Hypersensitivity to the active substance or any component of the investigation
Trial design
Design model
Crossover
Treatments tested in this trial
[177-Lu]Ludotadipep
Drug\[177-Lu\]Ludotadipep 3.7 GBq (+/- 10%) intravenously every 8 weeks for a maximum of 6 cycles.
Best supportive care/standard of care (BSC/SOC) alone
Other interventionBest supportive care/standard of care as defined by the investigator.
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: [177-Lu]Ludotadipep plus best supportive care/standard of care (BSC/SOC)Experimental treatment 2 interventions
Group B: BSC/SoCActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Radiographic Progression-Free Survival (rPFS)
Radiographic progression-free survival (rPFS) is defined as the time from the date of randomization to the date of first documented radiographic disease progression or death from any cause, whichever occurs first, as assessed by blinded independent central review (BICR) according to PCWG3-modified RECIST version 1.1. Median rPFS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented. Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score \[\>178 vs. ≤178\], ECOG performance status \[0-1 vs. 2\], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Time frame
up to 36 months.Secondary outcomes
1
Radiographic Progression-Free Survival (rPFS)
Radiographic progression-free survival (rPFS) is defined as the Time from the date of randomization to the date of first documented radiographic disease progression or death from any cause, whichever occurs first, as assessed by blinded independent central review (BICR) and investigator according to RECIST version 1.1 and RECIP 1.0(RECIP BICR Only). Median rPFS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented. Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score \[\>178 vs. ≤178\], ECOG performance status \[0-1 vs. 2\], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Time frame
up to 36 months.2
Overall Survival (OS)
Overall survival (OS) is defined as the time from the date of randomization to the date of death from any cause. Median OS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented. Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score \[\>178 vs. ≤178\], ECOG performance status \[0-1 vs. 2\], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Time frame
up to 36 months.3
Duration of Response (DOR)
Duration of response (DOR) is defined as the time from the date of first documented partial response (PR) or complete response (CR) to the date of first documented radiographic disease progression (PD), as assessed by blinded independent central review (BICR) and investigator according to RECIST v1.1, PCWG3-modified RECIST v1.1, and RECIP 1.0 (RECIP BICR only). Median DOR and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented. Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score \[\>178 vs. ≤178\], ECOG performance status \[0-1 vs. 2\], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Time frame
up to 36 months.4
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of first documented radiographic progression, PSA progression, clinical progression, or death from any cause, whichever occurs first, as assessed by investigator according to RECIST v1.1 and PCWG3-modified RECIST v1.1. Median PFS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented. Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score \[\>178 vs. ≤178\], ECOG performance status \[0-1 vs. 2\], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Time frame
up to 36 months. Source ClinicalTrials.gov